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Effect of the Consumption of a Cheese Enriched With Probiotic Organisms in Improving Symptoms of Constipation

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ClinicalTrials.gov Identifier: NCT01680432
Recruitment Status : Completed
First Posted : September 7, 2012
Last Update Posted : September 7, 2012
Sponsor:
Information provided by (Responsible Party):
Thaís Rodrigues Moreira, Centro Universitário Univates

Brief Summary:

Constipation is a common gastrointestinal motility disorder, chronic condition that often negatively affects the daily lives of patients due to their symptoms, such as infrequent stools, hard stools, straining or painful defecation, cramping, bloating and flatulence. Stress, poor diet and sedentary lifestyle are part of modern lifestyle, which contributes to the onset of constipation. One way to reduce constipation through nutritional management of affected individuals is through consumption of probiotic products, which beneficially affect the development of microbial flora in the intestine, helping to improve the symptoms of constipation. Among these foods, the market is a fresh cheese, plus Bifidobacterium lactis, which according to its maker, when consumed as part of a healthy diet, presents beneficial effects in improving symptoms of constipation.

Hypothesis: The fresh cheese enriched with Bifidobacterium lactis relieves symptoms constipation.


Condition or disease Intervention/treatment
Constipation Dietary Supplement: Probiotic fresh cheese Dietary Supplement: Regular Cheese

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Effect of the Consumption of a Cheese Enriched With Probiotic Organisms (Bifidobacterium Lactis Bi-07) in Improving Symptoms of Constipation: a Randomized Controlled Trial
Study Start Date : January 2012
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Probiotic cheese
The group received, for 30 days, was instructed to eat 30 g/day of probiotic fresh cheese enriched with Bifidobacterium lactis Bi-07.
Dietary Supplement: Probiotic fresh cheese
Participants in the intervention group were instructed to drink 30 grams of fresh cheese enriched with probiotics daily for 30 consecutive days.
Other Name: Fresh cheese enriched with Bifidobacterium lactis Bi-07
Placebo Comparator: Regular Cheese
The group placebo received, for 30 days, was instructed to consume 30g/day of regular fresh cheese.
Dietary Supplement: Regular Cheese



Primary Outcome Measures :
  1. Increase in frequency of bowel movements after eating probiotic cheese enriched [ Time Frame: 1 month ]


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adults constipated.

Exclusion Criteria:

  • Pregnant women
  • Individuals who report to be suffering from other diseases of the intestine;
  • Individuals who report not eat cheese, either for reasons of taste or intolerances / food allergies
  • Individuals who do not agree to participate and do not sign the term of informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680432


Locations
Brazil
Diane Cássia Fravetto
Guaporé, RS, Brazil, 95900000
Sponsors and Collaborators
Centro Universitário Univates
Investigators
Principal Investigator: Thaís R Moreira University Center Univates

Responsible Party: Thaís Rodrigues Moreira, Professor, Centro Universitário Univates
ClinicalTrials.gov Identifier: NCT01680432     History of Changes
Other Study ID Numbers: 033/11
First Posted: September 7, 2012    Key Record Dates
Last Update Posted: September 7, 2012
Last Verified: September 2012

Keywords provided by Thaís Rodrigues Moreira, Centro Universitário Univates:
constipation
probiotics
bifidobacterium
cheese

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms